ClinicalTrials.gg
Status unknownNCT03461822ESRTSPIOCUpdated Mar 12, 2018

Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

An observational study in Radiotherapy, sponsored by The National Center of Oncology, Azerbaijan. Status unknown at 1 site in Azerbaijan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-12.

Sponsored by The National Center of Oncology, Azerbaijan · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer.

Read the detailed description

Despite the fact that of many investigations in the world clinical researches, the SRT of primary-inoperabel and metastatic solid tumors combined with conventional and conformal radiation therapy methods the possibility of the sequences, the optimal fractions of the regimes and doses which determines normal tissues toxic manifestations, implementation of prevention, have not been solved yet.

The conducted research works to study quality of life for improving the social status of patients with primary-inoperable and metastatic solid tumors, is not fully resolved.

Thus, preparing of highly effective treatment tactics in primary-inoperable and metastatic solid tumors, is one of the most important problems of modern clinical oncology and this fact gives grounds to carry out the planned research work.

02

Conditions studied

  • Radiotherapy
03

In context

Lead sponsor

The National Center of Oncology, Azerbaijan is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The groups will be selected from patients which referred to National Center of Oncology and matching for conducting radiotherapy and Eligibility Criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed primary-inoperable solid tumors or oligometastatic cancer.
  • Acceptance of patient by surgeon as non-operabel or refusing of surgery.
  • No more than 4 foci in irradiated organ.
  • scale more than 60.
  • Age ≥18 years.
  • Estimated duration of life >3 months.
  • ≥ 8 g/dl.
  • at least 1,500/mm\^3.
  • count at least 70,000/mm\^3.
  • no greater than 1.5 times normal.
  • and SGPT no greater than 3 times normal.
  • Creatinine less than 1.5 mg/dL. PT-/APTT less than 1.5.
  • Last patients data no older than 1 month.
  • No prior radiotherapy of same location.
  • Prior chemottherapy more than 2 weeks ago.

Exclusion criteria

Exclusion Criteria:

  • Progression of primary site of cancer.
  • Pregnancy or Breast-Feeding.
  • Decompensated concomitant diseases.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • SRT in primary-inoperable solid tumors

    stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in primary-inoperable solid tumors

  • Classic radiotherapy in primary-inoperable solid tumors

    Classic radiotherapy in 1.8-2.0 Gy per fraction in primary-inoperable solid tumors

  • SRT in oligometastatic cancer

    stereotactic radiotherapy in hypofractionated regimes in 1-5 fractions in oligometastatic cancer

  • Classic radiotherapy in oligometastatic cancer

    Classic radiotherapy in 1.8-2.0 Gy per fraction in oligometastatic cancer

06

What researchers measure

Primary outcomes

  1. Relapse Rate (local and/or distant)

    clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases

    Time frame: 5 years

  2. Number of Deaths Due to Any Cause

    Deaths due to any complications or progression of previously diagnosed oncological diaseases

    Time frame: 5 years

Secondary outcomes

  1. Incidence of acute toxicity

    Number of adverse effects of irradiation observed in the patients within 3 months from the begginning of the treatment, measured by CTCAE 4.03 and/or EORTC/RTOG scales.

    Time frame: Up to 90 days after completion of radiation therapy

  2. Incidence of late toxicity

    Number of adverse effects of irradiation observed in the patients after 3 months from the begginning of the treatment, measured by LENT SOMA scale.

    Time frame: Up to 2 years after completion of radiation therapy

07

Study locations

1 of 1 sites recruiting
  • National Center of Oncology
    Baku, AZ1011, Azerbaijan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Dec 2019 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2018
First posted
Mar 12, 2018
Start
Mar 2013
Primary completionEst.
Dec 2019
CompletionEst.
Jan 2020
Last update
Mar 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03461822
Lead sponsor
The National Center of Oncology, Azerbaijan
Responsible party
Azer Aliyev (Radiation Oncologist, PhD, The National Center of Oncology, Azerbaijan) — Principal investigator
First posted
Mar 12, 2018
Start date
Mar 2013
Primary completion
Dec 2019 (estimated)
Completion
Jan 2020 (estimated)
Last update
Mar 12, 2018

Study contacts

Azer Aliyev, PhD
Contact
a.aliyev@yahoo.de
+994504054025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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